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EU Medical Devices Regulations Information Center

Here you will find some important documents to guide you in an application for certification against the new Medical Devices Regulation and In Vitro Diagnostic Medical Device Regulation.
The Medical Device Regulation (MDR) (EU) 2017/745 Certification Process

References

Formal Notification of Appeal
pdf0.13
MDR Unannounced Audit Questionnaire
pdf0.15
Medical Device Questionnaire
pdf0.24
Medical Device Regulation (MDR) Technical Documentation Request Form
pdf0.39
Medical Device Notification of Changes, Regulatory Action, Consultancy or Services Rendered
pdf2.43
Medical Devices Pre-Audit Client Questionnaire
pdf0.62
Notified Body Managers' Declaration of Interest
pdf1.88
Product Information Questionnaire
pdf0.78
Public Prices
pdf0.14
Relevant Subcontractors and Suppliers List
pdf0.23
System and Procedure Pack Product Information Questionnaire
pdf0.28

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Intercity Business Park, Generaal De Wittelaan 19 - A5,

2800,

Mechelen, Belgium